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PEDIATRICS Vol. 110 No. 2 August 2002, pp. 402-404

COMMENTARY

Protecting Research Participants

Howard Bauchner, MD

Boston Medical Center
Boston, MA 02118

Abbreviations: IRB, institutional review board • IOM, Institute of Medicine

The protection of human subjects in the United States is undergoing dramatic revision. Changes are occurring because of numerous controversies and concerns that have arisen over the last decade, including the inadequacies of institutional review boards (IRBs), ^1,2 the debate over research conducted in the developing world, ^3,4 violations of confidentiality in health services research, ⁵ changing concepts of informed consent,^6,7 and the growth of the clinical research endeavor.⁸

In this issue of Pediatrics, Weil and colleagues⁹ summarize the protection of human subjects in research reports published in 3 pediatric journals in 2000. Of 379 studies they reviewed, they found that 52% documented IRB approval, 42% documented informed consent, and only 35% properly documented both IRB review and informed consent. Their results are consistent with a number of other reviews, including our own, which suggest that a substantial proportion of research reports do not contain adequate information about the protection of human subjects.^10–15 They also found that the rate of reported IRB approval and informed consent varied by study design. This too is consistent with our work.¹¹ We found that 97% of randomized, clinical trials reported IRB approval, whereas only 70% of prospective cohorts, 37% of retrospective cohorts, and 9% of large dataset analyses reported approval. This suggests there is confusion about which types of studies need approval.

What role should individual investigators play in protecting human subjects? First, researchers must recognize their fundamental responsibility to those they are studying. Human subject protection is an obligation essential to the research endeavor. The primary mechanism ensuring appropriate protection of patients is review by an IRB. Although dealing with IRBs can be a tedious and time-consuming exercise, if a project involves human subjects, then investigators should seek approval from IRBs.

Second, clinicians and administrators should refrain from making the determination that a project is not research; that is the job of IRBs. Two areas of research that are particularly subject to confusion include quality improvement projects and health services. Casarett and colleagues¹⁶ suggest 2 criteria that can be used to determine whether a quality improvement initiative should be considered research and needs IRB approval. If either the majority of patients are not expected to benefit directly from the project or additional risks or burdens are imposed by the initiative, then the project should be considered research. The Institute of Medicine (IOM)⁵ describes quality improvement as research if the study explores unknown phenomena, collects data not routinely collected, compares alternative treatments, interventions, or processes, or manipulates current process. In general, the IOM suggests that if the intent or possible intent of the investigator is publication, then the project represents research and IRB approval is necessary.⁵

Even health services research, which often involves large databases that are relatively anonymous and include thousands of patients, requires IRB review. Although it generally poses no physical risks to patients, the IOM⁵ recently noted that health services research can violate both privacy and confidentiality. Privacy has been defined as the "the right to be left alone"¹⁷ and confidentiality refers to "controlling access to the information that an individual has already disclosed, for example, a patient to a treating physician or to an insurance company paying for care."⁵ It implies that further disclosure of information will not be allowed to occur without authorization. If patients do not trust that their confidentiality will be protected, then they may not seek care when appropriate, or disclose important information to health care providers. The IOM recommends that investigators should have all health services research reviewed by an appropriate review board regardless of the source of support or whether the research is subject to federal regulations.

Third, researchers should actively monitor progress in the field of human subjects protection by attending seminars and reading publications on research ethics in their field of inquiry. Attending seminars and receiving certified approval to conduct research is increasingly being monitored and mandated by many IRBs and institutions.

These basic steps for researchers complement the key role of IRBs in human subject protection. Review boards not only approve projects, but they also monitor ongoing research to assure that all applicable safeguards are followed. Unfortunately, in several recent cases, IRBs have been faulted for not applying independent judgment to research projects.^18,19 IRB reform must address the potential for conflicts of interest, the need for an active patient voice, and sufficient funding to assure the expertise and care needed for a thorough review.^1,2 IRBs can redesign applications and report forms for health services research to better assess risks to confidentiality and to assist investigators in complying with human subject requirements. An extensive list of recommendations for reform was recently proposed by the National Bioethics Advisory Committee (Table 1).²⁰

View this table: [in this window] [in a new window]   TABLE 1. Selected Recommendations from the National Bioethics Advisory Commission

 
The role that peer-reviewed publications play in protecting human subjects has evolved over the past few decades. Currently, >500 journals have adopted the Uniform Requirements of the International Committee of Medical Journal editors, which stipulates that authors should describe IRB approval.²¹ Despite journals’ acceptance of the International Committee of Medical Journal editors requirements, Amdur and Biddle²² found in their review of 102 research journals, that the majority made no mention of the necessity of obtaining and disclosing IRB approval or informed consent to the journal.

The importance of distinguishing between IRB approval and informed consent is highlighted by a recent controversy in the British Medical Journal²³ that published the results of 2 randomized, clinical trials^24,25 in which ethics committee approval was obtained, but the participants did not give written-informed consent. Numerous letters to the editor disagreed with the publication of these reports.^26,27 If the articles had simply contained statements regarding ethics committee approval, readers would have never known that informed consent had not been obtained.

I believe that peer-reviewed journals should become more aggressive in requiring statements regarding IRB approval for every research report. Just as structured abstracts have helped improve the quality of scientific reports, I believe that structured reporting of IRB approval would further the protection of human subjects. Key elements should included the following: if the IRB board determined whether the research was exempt and reason why; the type of approval obtained (full board, or expedited review); and if consent is necessary, the type of consent obtained (written or oral). Just as every research report includes a list of authors, every study should include information about the protection of human subjects. Peer-reviewed journals can play a greater role in oversight, particularly since publication is the final step for most research projects.

We applaud the report by Weil and colleagues. Their study highlights ongoing and persistent concerns about the protection of human subjects. We must not forget that vigorous protection of subjects’ rights is absolutely essential to public confidence in scientific progress. It is our privilege to conduct research, not our right.

	ACKNOWLEDGMENTS

 
I would like to acknowledge the many thoughtful conversations and comments of Josh Sharfstein, MD, and the helpful critiques by Robin Weinick, PhD, Peter Gergen, MD, and Joel Alpert, MD.

	FOOTNOTES

 
Received for publication Apr 12, 2002; Accepted Apr 12, 2002.

Address correspondence to Howard Bauchner, MD, Boston Medical Center, Maternity 4th Floor, 91 East Concord St, Boston, MA 02118. E-mail: howard.bauchner{at}bmc.gov

The views expressed in this article are those of the author and do not necessarily represent those of the Agency for Health care Research and Quality, or the US Department of Health and Human Services.

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PEDIATRICS (ISSN 1098-4275). ©2002 by the American Academy of Pediatrics

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